Regional Environmental Monitoring Specialist
Regional Environmental Monitoring Specialist
- Location: Bogotá
About the job
Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions, in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes and cardiovascular solutions.
We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Your job, as Regional Qualification Specialist within our M&S Services Bogota Hub, will be acting as a crucial link between our R&D and Manufacturing facilities, playing a vital role in securing the present portfolio and delivering future launches of high-quality and innovative drugs and vaccines.
We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible.
Main responsibilities:
- Organize and analyze environmental data using statistical software for trend analysis
- If applicable, translate the manufacturing site data package
- Prepare tables and graphs with the collected data, if applicable
- Perform data analysis according to the method defined in the protocol
- Check conformity against acceptance criteria defined in the protocol
- Identify, document, and report deviations, assessing their impact on results
- Prepare and add the list of deviations, change controls to report, prepare queries
- Cooperate with cross-functional teams (Regional manufacturing sites, global and other regional HUBs and specific project teams) to ensure smooth execution of issuance of report
- Support Regional Senior Specialist and Regional Expert in report writing
- Performing his/her tasks in accordance with cGMP and HSE requirements, and with the associated instructions, procedures, and records related to these tasks
- Informing his/her manager of any quality or HSE event (deviations, OOX, etc.) on time to ensure investigation and impact assessment are performed appropriately
- Investigating in a timely manner and resolving any quality control events, issues, or discrepancies within his/her perimeter
- Bringing, executing, and leading ideas to improve processes and “the way of work” of his/her area.
- Responsible for working to successfully achieve area KPIs targets.
- To keep an excellent working environment
- Translate and adapt report communications for sites, ensuring clarity and alignment with local requirements
- Collaborating with Global Team, Managers, Experts, and Sr. Specialists to support dedicated activities
- Ensure compliance with GxP principles, regulatory requirements, and the company’s Quality standards
- Manage Quality Management System (QMS) records, address discrepancies, and ensure timely closure of all related documentation
- Support internal and external audits, regulatory inspections, and corporate assessments, ensuring full preparedness and high quality documentation
- Participate in continuous improvement initiatives through standardization, simplification, and digitalization of processes
About you
- Experience: Experience in GMP, preferably with prior experience in EM reports or similar areas (stability management or QV).
- Experience in organizing and analyzing data using statistical tools.
- Familiarity with document management systems.
- Soft and technical skills: Attention to Detail: Strong attention to detail.
- Ability to work effectively within a team.
- Basic understanding of regulatory requirements.
- Quick learner with a proactive mindset.
- Ability to adapt quickly to changing environments.
- Capable of managing multiple tasks simultaneously and taking initiative.
- Demonstrates growing independence over time.
- Knowledge of automation tools such as Power BI and Power Automate.
- Education: Bachelor's degree in pharmacy, engineering, chemistry, biology, or related field.
- Languages: Advanced English level is a MUST.
Why choose us?
- Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
- You’ll be part of leading the first experiences a job seeker has with Sanofi and ensuring it is best-in-class and driving conversions.
- You’ll be part of a truly diverse cross-cultural team and can have real business impact.
- Flexible working policies, including up to 50% remote work.
- Private medical care, life and health insurance, and gender-neutral paid parental leave
- Colombia is one of Sanofi’s key locations for new talents, having a big footprint with the Bogota HUB and its best-in-class operation.
- Mexico and Argentina Play an instrumental part in creating best practice and innovation within our 3 vaccines production plants.
Pursue Progress. Discover Extraordinary.
Progress doesn’t happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.
At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.
To apply under the disability condition, it is necessary to have a certificate issued in accordance with the provisions of the Ministry of Health and Social Protection to comply with the obligations established in Law 2466 of 2025 regarding the hiring of people with disabilities.
If you require any reasonable accommodation or adjustment during the recruitment process, please inform the Talent Acquisition team. This information will be treated confidentially and will not impact your application.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
Pursue progress, discover extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!